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Trastuzumab in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer That Overexpresses HER2
This study has been completed.
First Received: March 7, 2000   Last Updated: February 6, 2009   History of Changes
Sponsor: Cancer and Leukemia Group B
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00004883
  Purpose

RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.

PURPOSE: Phase II trial to study the effectiveness of trastuzumab in treating patients who have stage IIIB or stage IV non-small cell lung cancer that overexpresses HER2.


Condition Intervention Phase
Lung Cancer
Biological: trastuzumab
Phase II

Study Type: Interventional
Study Design: Treatment
Official Title: A Phase II Trial of Trastuzumab (Herceptin) for Advanced Stage (IIIB, IV), HER2 Overexpressing, Non-Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: February 2000
Detailed Description:

OBJECTIVES:

  • Determine the activity of trastuzumab (Herceptin) in patients with stage IIIB or IV HER2-overexpressing non-small cell lung cancer.
  • Determine the duration of response in patients treated with this regimen.
  • Determine the toxicity of this treatment regimen in this patient population.
  • Assess levels of circulating HER2 and correlate with HER2 expression in this patient population.

OUTLINE: Patients are stratified according to prior treatment (yes vs no).

Patients receive trastuzumab (Herceptin) IV over 30-90 minutes on day 1. Treatment continues once a week in the absence of disease progression or unacceptable toxicity.

Patients are followed every 8 weeks until disease progression or death.

PROJECTED ACCRUAL: Approximately 84 patients (42 per stratum) will be accrued for this study within 17.5 months.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed stage IIIB or IV non-small cell lung cancer

    • Supraclavicular node involvement allowed
    • Malignant pleural effusion allowed (cytological confirmation not required if pleural fluid bloody or exudative)
  • No stage IIIB patients eligible for CLB protocols comprising combined chemotherapy and chest radiotherapy
  • Recurrent disease allowed
  • HER2 overexpression (2-3+)
  • At least 1 unidimensionally measurable lesion

    • At least 20 mm by conventional techniques OR
    • At least 10 mm by spiral CT scan
    • The following are not considered measurable:

      • Bone lesions
      • Leptomeningeal disease
      • Ascites
      • Pleural/pericardial effusion
      • Abdominal masses not confirmed and followed by imaging
      • Cystic lesions
  • No CNS metastases

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • Not specified

Hematopoietic:

  • Granulocyte count at least 1,500/mm3
  • Platelet count at least 100,000/mm3

Hepatic:

  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)

Renal:

  • Creatinine no greater than 1.5 times ULN

Cardiovascular:

  • LVEF at least 45% (by echocardiogram or MUGA)

Other:

  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • HIV negative
  • No concurrent immunologic disease (e.g., autoimmune disease)
  • No history of allergy to murine products

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No prior murine antibodies

Chemotherapy:

  • See Disease Characteristics
  • No prior anthracyclines
  • No more than 1 prior chemotherapy regimen for lung cancer
  • At least 4 weeks since prior chemotherapy
  • No concurrent chemotherapy

Endocrine therapy:

  • No concurrent steroids except for adrenal failure or dexamethasone as an antiemetic
  • No concurrent hormonal therapy except for nondisease-related conditions (e.g., insulin for diabetes)

Radiotherapy:

  • See Disease Characteristics
  • At least 6 months since prior radiotherapy
  • No concurrent palliative radiotherapy

Surgery:

  • At least 4 weeks since prior major surgery
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004883

  Hide Study Locations
Locations
United States, Alabama
Veterans Affairs Medical Center - Birmingham
Birmingham, Alabama, United States, 35233-1996
United States, California
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, United States, 94143-0128
University of California San Diego Cancer Center
La Jolla, California, United States, 92093-0658
Veterans Affairs Medical Center - San Francisco
San Francisco, California, United States, 94121
United States, Delaware
CCOP - Christiana Care Health Services
Wilmington, Delaware, United States, 19899
United States, District of Columbia
Lombardi Cancer Center
Washington, District of Columbia, United States, 20007
Walter Reed Army Medical Center
Washington, District of Columbia, United States, 20307-5000
United States, Florida
CCOP - Mount Sinai Medical Center
Miami Beach, Florida, United States, 33140
United States, Illinois
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637-1470
Veterans Affairs Medical Center - Chicago (Westside Hospital)
Chicago, Illinois, United States, 60612
United States, Iowa
Hematology Oncology Associates of the Quad Cities
Bettendorf, Iowa, United States, 52722
Holden Comprehensive Cancer Center at The University of Iowa
Iowa City, Iowa, United States, 52242-1009
United States, Maine
Veterans Affairs Medical Center - Togus
Togus, Maine, United States, 04330
United States, Maryland
Marlene & Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, United States, 01655
United States, Minnesota
University of Minnesota Cancer Center
Minneapolis, Minnesota, United States, 55455
Veterans Affairs Medical Center - Minneapolis
Minneapolis, Minnesota, United States, 55417
United States, Missouri
Barnes-Jewish Hospital
Saint Louis, Missouri, United States, 63110
Ellis Fischel Cancer Center - Columbia
Columbia, Missouri, United States, 65203
Veterans Affairs Medical Center - Columbia (Truman Memorial)
Columbia, Missouri, United States, 65201
United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198-3330
United States, Nevada
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, United States, 89106
United States, New Hampshire
Norris Cotton Cancer Center
Lebanon, New Hampshire, United States, 03756-0002
United States, New York
CCOP - North Shore University Hospital
Manhasset, New York, United States, 11030
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
Syracuse, New York, United States, 13217
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Mount Sinai Medical Center, NY
New York, New York, United States, 10029
New York Presbyterian Hospital - Cornell Campus
New York, New York, United States, 10021
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
Schneider Children's Hospital at North Shore
Manhasset, New York, United States, 11030
State University of New York - Upstate Medical University
Syracuse, New York, United States, 13210
Veterans Affairs Medical Center - Buffalo
Buffalo, New York, United States, 14215
Veterans Affairs Medical Center - Syracuse
Syracuse, New York, United States, 13210
United States, North Carolina
CCOP - Southeast Cancer Control Consortium
Winston-Salem, North Carolina, United States, 27104-4241
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, United States, 27157-1082
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, United States, 27599-7295
Veterans Affairs Medical Center - Durham
Durham, North Carolina, United States, 27705
United States, Ohio
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, United States, 43210-1240
United States, Rhode Island
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
United States, Tennessee
University of Tennessee, Memphis Cancer Center
Memphis, Tennessee, United States, 38103
Veterans Affairs Medical Center - Memphis
Memphis, Tennessee, United States, 38104
United States, Vermont
Green Mountain Oncology Group
Bennington, Vermont, United States, 05201
Vermont Cancer Center
Burlington, Vermont, United States, 05401-3498
Veterans Affairs Medical Center - White River Junction
White River Junction, Vermont, United States, 05009
United States, Virginia
MBCCOP - Massey Cancer Center
Richmond, Virginia, United States, 23298-0037
Veterans Affairs Medical Center - Richmond
Richmond, Virginia, United States, 23249
Sponsors and Collaborators
Cancer and Leukemia Group B
Investigators
Study Chair: Gerald H. Clamon, MD Holden Comprehensive Cancer Center
  More Information

Additional Information:
Publications:
Study ID Numbers: CDR0000067555, CLB-39810
Study First Received: March 7, 2000
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00004883     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent non-small cell lung cancer
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer

Additional relevant MeSH terms:
Thoracic Neoplasms
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Antineoplastic Agents
Pharmacologic Actions
Carcinoma
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Therapeutic Uses
Lung Diseases
Trastuzumab
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 27, 2009